'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula (OPTIMARF)

University of Padova

Status: Completed

Conditions: Hypoxemia

Treatments: Device: Symmetrical high flow nasal cannula (HFNO); Device: Asymmetrical high flow nasal cannula (DUET HFNO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05838326

AOP2949

Details and patient eligibility

About

High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.

Full description

A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18 years old;
• invasive mechanical ventilation > 24h;
• acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio < 300;
• absence of Sars-Cov-2 positivity;
• absence of cardiological or long-term respiratory disease

Exclusion criteria

• pregnancy
• tracheostomy
• non-invasive ventilation after extubation
• second tracheal intubation
• contraindications for EIT belt
• facial or nose abnormalities

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Symmetrical high flow nasal cannula (HFNO)

Active Comparator group

Description:

After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a arterial oxygen pressure (PaO2) and inspiratory oxygen fraction (FiO2) ratio \< 300, patients will be randomly assigned to a first 1h-phase of 'conventional HFNO' or 'DUET HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60 L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain a peripheral saturation (SpO2) between 92 and 98%.

Treatment:

Device: Symmetrical high flow nasal cannula (HFNO)

Asymmetrical high flow nasal cannula (DUET HFNO)

Active Comparator group

Description:

After a 'baseline' trial using Venturi Mask, within the first 120 minutes after extubation, and assessing a PaO2/FiO2 ratio \< 300 (as described above), patients will be randomly assigned to a second 1h-phase of 'DUET HFNO' vs 'conventional HFNO'. At the end of each session several clinical parameters (i.e. DUS, EIT, ABGs, comfort, VAS) will be collected. Specifically, Gas-flow rate will be set at a maximum of 60L/min, temperature at a maximum of 37°C, while FiO2 will be adjusted to maintain SpO2 between 92 and 98%.

Treatment:

Device: Asymmetrical high flow nasal cannula (DUET HFNO)